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510(k) Data Aggregation

    K Number
    K173436
    Device Name
    Luma Light System
    Manufacturer
    Luma Therapeutics
    Date Cleared
    2018-01-30

    (88 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Luma Therapeutics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LUMA™ Light System is an Ultraviolet Light Emitting Medical Device. It is intended for use in localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), sebhoic dermatitis, and leukoderma on all skin types (I-VI).
    Device Description
    The Luma Light System is a phototherapy system intended to treat dermatological conditions such as psoriasis. The system includes a light module, an Android Nexus 4 phone, a software-based phone application (app), and a device charger. The light module contains light emitting diodes (LEDs), which create an array of narrowband UVB light centered at a wavelength between 300 - 320 nm. The light module attaches to a dressing applied to the patient's affected skin to allow for passive dosing of the lesion. This is a home use device intended to be used and operated by the patient (see technical specifications for environmental limitations). A physician will determine the dose and frequency of treatment. The app is then used by the patient to deliver treatments, provide treatment reminders and store data about prior treatments.
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